Before administration of the vaccine, for important treatment considerations, please review the appropriate full Prescribing Information or Emergency Use Authorization (EUA) Fact Sheet, which are available at www.pfizermedicalinformation.com/en-us/pfizer-biontech-covid-19-vaccine or www.cvdvaccine.com. 

Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 12 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. 

Bivalent Vaccine

The U.S. Food and Drug Administration (FDA) has issued an EUA to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) for active immunization to prevent COVID‑19 in individuals 12 years of age and older. 

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent. It is supplied in multiple dose vials with gray caps and labels with gray borders. 

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved monovalent* COVID‑19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine. 

Original [Monovalent]* Vaccines

COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine are also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.  There are 2 formulations for use in individuals 12 years of age and older: multiple dose vials with a gray cap and label with a gray border (NOT DILUTED PRIOR TO USE) and multiple dose vials with a purple cap (MUST BE DILUTED PRIOR TO USE). 

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA‑authorized Pfizer-BioNTech COVID-19 Vaccines for individuals 12 years of age and older when prepared according to their respective instructions for use can be used interchangeably without presenting any safety or effectiveness concerns. 

Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with an orange cap and a label with an orange border is authorized for use to provide: a 2-dose primary series to individuals 5 through 11 years of age; a third primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise; and a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine. 

Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a maroon cap and a label with a maroon border is authorized for use to provide a 3-dose primary series to individuals 6 months through 4 years of age. 

*Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.